FDA Expands Dermatology Drug Labels in 2025 with Five New Indications Across Multiple Skin Conditions
核心洞察
The FDA approved five new indications for previously approved dermatology drugs in 2025, including two additional approvals for Dupixent, bringing its total approved indications to eight diseases.
Zoryve (roflumilast) received expanded approvals for both cream formulation in young children with atopic dermatitis (搜索) and foam formulation for plaque psoriasis (搜索) in adolescents and adults.
Opzelura (ruxolitinib) became the first topical JAK (搜索) inhibitor approved for pediatric atopic dermatitis (搜索) patients ages 2-11 years in the United States.
The FDA approved five new indications for previously approved dermatology medications in 2025, significantly expanding treatment options across multiple skin conditions. The approvals included two new indications for Dupixent (dupilumab), bringing the total number of diseases for which it is FDA-approved to eight, along with expanded labels for Opzelura (ruxolitinib) and Zoryve (roflumilast).
Zoryve Expands Into Pediatric Population and Psoriasis Treatment
In October 2025, the FDA expanded the label of Zoryve (roflumilast) cream 0.05% as a topical treatment for mild to moderate atopic dermatitis (搜索) in children ages 2 to 5 years. This approval was notable because it extended the cream's approval into the very young pediatric population, despite the drug already being approved in various concentrations for plaque psoriasis (搜索) and atopic dermatitis.
Earlier in May 2025, the FDA approved Zoryve foam 0.3% as a topical treatment for plaque psoriasis (搜索) of the scalp and body in adults and adolescents aged 12 and older. The once-daily foam formulation became the first topical foam approved for psoriasis and may be especially beneficial for treatment in hair-bearing and sensitive areas.
Zoryve is a topical PDE4 (搜索) inhibitor designed to block a key inflammatory enzyme involved in psoriasis pathogenesis. While PDE4 inhibition is not new as a mechanism of action, Zoryve is a more potent PDE4 inhibitor compared to treatments such as Eucrisa (crisaborole) and Otezla.
"It is spectacular that roflumilast 0.3% foam is now approved for scalp and body psoriasis in adolescents and adults," said Dermatology Times Editor in Chief Christopher Bunick, M.D., Ph.D. "This amazing foam vehicle not only delivers the highly potent PDE4 (搜索) inhibitor roflumilast to the sites where patients need it most, but it does so in an elegant fashion."
Opzelura Becomes First Pediatric JAK Inhibitor
In October 2025, the FDA approved Opzelura (ruxolitinib) as a treatment for mild to moderate atopic dermatitis (搜索) in children ages 2 to 11 years. The label expansion made Opzelura the first topical Janus kinase (JAK (搜索)) inhibitor approved for the pediatric population in the United States.
The approval was based on the phase 3 TRuE-AD3 study, which enrolled 330 children ages 2 to 11 years with mild to moderate atopic dermatitis (搜索). Results showed that significantly more children treated with ruxolitinib achieved the primary endpoint of investigator's global assessment treatment success (IGA-TS) compared with an inactive vehicle. Response rates were 36.6% with 0.75% cream and 56.5% with 1.5% cream compared with 10.8% for vehicle.
"This gives us another tool in a much-needed area," said Peter Lio, MD, a clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine. "A rapid, steroid-sparing option that meaningfully reduces itch within days helps us control flares without escalating to systemic therapy and can help minimize the use of topical steroids."
Opzelura was originally approved in 2011 as a treatment for atopic dermatitis (搜索) in adolescents and adults, with FDA approval for nonsegmental vitiligo following in 2022.
Libtayo Approved for High-Risk Skin Cancer Prevention
In October 2025, the FDA approved Libtayo (cemiplimab) as a treatment for cutaneous squamous cell carcinoma (搜索) that has a high risk of recurring after treatment with surgery and radiation. As a PD-1 (搜索) inhibitor, Libtayo targets receptors on T cells, unleashing them to recognize and attack cancer cells.
Originally approved in 2018, Libtayo had previously been approved for metastatic and locally advanced basal cell carcinoma and certain types of non-small cell lung cancer. The original approval was for metastatic cutaneous squamous cell carcinoma (搜索) or locally advanced disease in individuals who weren't candidates for curative surgery or radiation.
"Patients whose CSCC [cutaneous squamous cell carcinoma (搜索)] is at a high risk of recurrence following surgery and radiation often have the poorest outcomes," said Vishal A. Patel, M.D., associate professor of dermatology and hematology/oncology at George Washington University. "Until now, we lacked options to help prevent a devastating recurrence, and immunotherapy was only available for patients with advanced CSCC who were no longer candidates for curative surgery or curative radiation."
Dupixent Gains Two Additional Indications
In June 2025, the FDA approved Dupixent as a treatment for adult patients with bullous pemphigoid (搜索) (BP), a rare inflammatory skin disease. Earlier in April, the FDA approved the resubmitted application of Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (搜索) (CSU).
Dupixent inhibits the signaling of interleukin-4 (搜索) and interleukin-13 (搜索), key drivers of the type 2 inflammation that underlies many chronic allergic and inflammatory conditions. The FDA had previously approved Dupixent for atopic dermatitis (搜索), asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.
Bullous pemphigoid (搜索) is an autoimmune skin disorder that mainly affects older adults, with symptoms including severe itching, blisters, lesions and skin breakdown. A study published in the Journal of the American Academy of Dermatology estimated the prevalence in the U.S. to be 12 per 100,000 adults, increasing to nearly 38 per 100,000 among those aged 60 and older.
Chronic spontaneous urticaria (搜索) is a chronic inflammatory skin disease driven in part by type 2 inflammation. More than 300,000 people in the United States have chronic spontaneous urticaria that is inadequately controlled by antihistamines, the typical first-line treatment.
Gene Therapy Expansion for Rare Disease
In September 2025, the FDA expanded the label for Vyjuvek (beremagene geperpavec) to include dystrophic epidermolysis bullosa (搜索) patients from birth. The changes also modified wound dressing requirements to make at-home use feasible.
Vyjuvek is a herpes-simplex virus type 1 vector-based gene therapy indicated for treating dystrophic epidermolysis bullosa (搜索) with mutations in the COL7A1 (搜索) gene. It delivers two copies of the COL7A1 gene when applied directly to dystrophic epidermolysis bullosa wounds. The drug was originally approved in 2023 for this rare subtype of epidermolysis bullosa characterized by extreme skin fragility affecting the deeper dermal layer beneath the epidermis.